Depuy Pinnacle with Gription Acetabular Cups
FDA 510(k) K093646 · DePuy Orthopaedics, Inc.
510(k) numberK093646
Submission
- Device name
- Depuy Pinnacle with Gription Acetabular Cups
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- November 25, 2009
- Decision date
- December 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Depuy Pinnacle with Gription Acetabular Cups cleared by the FDA?
Depuy Pinnacle with Gription Acetabular Cups (K093646) received a 510(k) decision of Substantially Equivalent on December 17, 2009, 22 days after the submission was received.
What is the product code of K093646?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.